Senior Clinical Research Associate

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Ensure the appropriate execution of clinical trials in line with the Study Monitoring Plan, relevant laws, and Good Clinical Practices.

• Oversee operational components of clinical trial activities at designated investigator sites, from site activation to database lock.

• Guarantee that applicable timelines and quality deliverables are achieved.

• Facilitate communication among study team members, vendors, and assigned investigator sites.

• Monitor site-level Adverse Events (AEs) and Serious Adverse Events (SAEs).

• Collaborate with the Drug Safety Unit and follow up with investigator sites to gather necessary SAE report information.

• Act as a point of contact during audits.

• Lead the development of Audit Observation Corrective and Preventive Actions (CAPA) and conduct checks as required.

⛳️ Requirements

• Bachelor's degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or a medical background, or equivalent.

• In-depth understanding of clinical trial methodologies, ICH/GCP guidelines, FDA regulations, and local country laws.

• At least 3.5 years of relevant experience in clinical research site monitoring.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Comprehensive health benefits, including medical, dental, and vision coverage.

• Flexible working hours and remote work options.

• Supportive and inclusive work environment.